Adverse Events Module
For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.
Adverse Events Module path is as follows:
Study -> Results Section -> Adverse Events Module -> Event Groups
Study -> Results Section -> Adverse Events Module -> Serious Events
Study -> Results Section -> Adverse Events Module -> Other Events
Adverse Events Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:49 PM
NCT ID:
NCT05028569
Description:
Participants were analyzed according to the study treatment that they actually received at the first injection cycle on Day 1. For safety analysis, there was 1 participant who belonged to a different treatment group than assigned by randomization (BOTOX 195 U instead of BOTOX 155 U).
Frequency Threshold:
5
Time Frame:
All-cause mortality and adverse event tables include events reported from time informed consent was signed to end of the study. Median time on follow-up was 30 days in the Screening/Baseline Phase; 168 days in the Double-Blind Phase; and 169 days in the Open-Label Phase.
Study:
NCT05028569
Study Brief:
Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine
Event Groups(If Any):
Event Groups
| Title | Description | Deaths # Affected | Deaths # At Risk | Serious # Affected | Serious # At Risk | Other # Affected | Other # At Risk | View |
|---|---|---|---|---|---|---|---|---|
| Double-Blind Phase: BOTOX 155 U | Participants received intramuscular injections in the head/neck muscles of BOTOX 155 U on Day 1 and Week 12. | 0 | None | 3 | 256 | 35 | 256 | View |
| Double-Blind Phase: Placebo/Open-Label Phase: BOTOX 195 U | Participants who received placebo for BOTOX intramuscular injections in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase. | 0 | None | 2 | 217 | 19 | 217 | View |
| Double-Blind Phase: BOTOX 155 U/Open-Label Phase: BOTOX 195 U | Participants who received intramuscular injections of BOTOX 155 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase. | 0 | None | 1 | 227 | 18 | 227 | View |
| Double-Blind Phase: BOTOX 195 U/Open-Label Phase: BOTOX 195 U | Participants who received intramuscular injections of BOTOX 195 U in the head/neck muscles on Day 1 and Week 12 during the Double-Blind Phase who then received intramuscular injections of BOTOX 195 U in the head/neck muscles on Weeks 24 and 36 in the Open-Label Phase. | 1 | None | 1 | 223 | 14 | 223 | View |
| Screening/Baseline Phase | Participants with 6 to 14 migraine days and \< 15 headache days per month in each of the 3 months prior to the screening visit (Visit 1) and during the 4-week Screening/Baseline Phase were randomized in this study. | 0 | None | 2 | 775 | 14 | 775 | View |
| Double-Blind Phase: Placebo | Participants received placebo intramuscular injections in the head/neck muscles for BOTOX on Day 1 and Week 12. | 0 | None | 6 | 257 | 21 | 257 | View |
| Double-Blind Phase: BOTOX 195 U | Participants received intramuscular injections in the head/neck muscles of BOTOX 195 U on Day 1 and Week 12. | 1 | None | 6 | 262 | 22 | 262 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| IMMUNE THROMBOCYTOPENIA | SYSTEMATIC_ASSESSMENT | Blood and lymphatic system disorders | MedDRA 27.1 | View |
| VESTIBULAR DISORDER | SYSTEMATIC_ASSESSMENT | Ear and labyrinth disorders | MedDRA 27.1 | View |
| PORTOSPLENOMESENTERIC VENOUS THROMBOSIS | SYSTEMATIC_ASSESSMENT | Hepatobiliary disorders | MedDRA 27.1 | View |
| STAPHYLOCOCCAL ABSCESS | SYSTEMATIC_ASSESSMENT | Infections and infestations | MedDRA 27.1 | View |
| ANKLE FRACTURE | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.1 | View |
| FALL | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.1 | View |
| TRAUMATIC HAEMATOMA | SYSTEMATIC_ASSESSMENT | Injury, poisoning and procedural complications | MedDRA 27.1 | View |
| INTERVERTEBRAL DISC PROTRUSION | SYSTEMATIC_ASSESSMENT | Musculoskeletal and connective tissue disorders | MedDRA 27.1 | View |
| LIPOSARCOMA | SYSTEMATIC_ASSESSMENT | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 27.1 | View |
| MIGRAINE | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.1 | View |
| MIGRAINE WITH AURA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.1 | View |
| MYELOPATHY | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.1 | View |
| SCIATICA | SYSTEMATIC_ASSESSMENT | Nervous system disorders | MedDRA 27.1 | View |
| COMPLETED SUICIDE | SYSTEMATIC_ASSESSMENT | Psychiatric disorders | MedDRA 27.1 | View |
| BENIGN PROSTATIC HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 27.1 | View |
| BREAST HYPERPLASIA | SYSTEMATIC_ASSESSMENT | Reproductive system and breast disorders | MedDRA 27.1 | View |
| DYSPNOEA | SYSTEMATIC_ASSESSMENT | Respiratory, thoracic and mediastinal disorders | MedDRA 27.1 | View |
| ABORTION INDUCED | SYSTEMATIC_ASSESSMENT | Surgical and medical procedures | MedDRA 27.1 | View |
| HYPERTENSION | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.1 | View |
| LABILE BLOOD PRESSURE | SYSTEMATIC_ASSESSMENT | Vascular disorders | MedDRA 27.1 | View |